Ignite Creation Date:
2025-12-18 @ 9:35 AM
Ignite Modification Date:
2025-12-18 @ 9:35 AM
Study NCT ID:
NCT03911778
Status:
None
Last Update Posted:
2024-01-11 00:00:00
First Post:
2019-04-10 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evolution of Symptoms After Sacrospinofixation With Posterior Isthmic Band
Sponsor:
None
Organization:
Study Overview
Official Title:
Prospective Study of the Evolution of Symptoms After Sacrospinofixation With Posterior Isthmic Band
Status:
None
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPIP
Brief Summary:
Prolapse is a condition that can cause disabling pelvic, urinary or sexual function disorders and impaired quality of life.
Regarding the prolapse of the middle floor, the vaginal sacrospinofixation according to Richter is the reference technique for the suspension of the vaginal fundus. But the technique of sacrospinofixation vaginally is not without several difficulties in the short term but also in the medium and long term.
Recently, anchoring devices have been developed to limit the dissection of the sacrospinous ligament and the operative exposure by the sometimes traumatic valves.
The investigating team uses a technical variant in the form of an isthmic posterior strip of light weight and whose arms are sutured to the sacrospinous ligaments. The advantages of this isthmic strip are based on its small size, its very low basis weight and its wide mesh (improvement of tolerance) via a mini-invasive vaginal approach (thus allowing ambulatory care).
Patient functional discomfort is the main problem related to the presence of a prolapse, therefore, the researchers wish to evaluate patient feelings following the use of this isthmic band. The researchers' hypothesis is that the sacrospinofixation technique with posterior isthmic band Bilateral Sacrospinous Colposuspension (BSC) Mesh (Agency for Medical Innovations (AMI) laboratory) improves symptoms experienced by patients with mid-level prolapse.
Regarding the prolapse of the middle floor, the vaginal sacrospinofixation according to Richter is the reference technique for the suspension of the vaginal fundus. But the technique of sacrospinofixation vaginally is not without several difficulties in the short term but also in the medium and long term.
Recently, anchoring devices have been developed to limit the dissection of the sacrospinous ligament and the operative exposure by the sometimes traumatic valves.
The investigating team uses a technical variant in the form of an isthmic posterior strip of light weight and whose arms are sutured to the sacrospinous ligaments. The advantages of this isthmic strip are based on its small size, its very low basis weight and its wide mesh (improvement of tolerance) via a mini-invasive vaginal approach (thus allowing ambulatory care).
Patient functional discomfort is the main problem related to the presence of a prolapse, therefore, the researchers wish to evaluate patient feelings following the use of this isthmic band. The researchers' hypothesis is that the sacrospinofixation technique with posterior isthmic band Bilateral Sacrospinous Colposuspension (BSC) Mesh (Agency for Medical Innovations (AMI) laboratory) improves symptoms experienced by patients with mid-level prolapse.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: